CLINUVEL has expanded its clinical program to evaluate the DNA reparative potential of afamelanotide in skin cells which have been damaged by ultraviolet (UV) and sun exposure. The program now includes patients with the rare disorders XP-V and XP-C. Having reached agreement with clinical and academic experts, CLINUVEL will generate clinical data on the safety and efficacy of SCENESSE (afamelanotide 16mg). UV radiation penetrates into the nucleus of skin cells and causes defects of the DNA helix known as photoproducts. If left unrepaired, these chemical changes to DNA may replicate as mutations, leading to irreversible damage (photoaging) and may further progress to skin cancer, including melanoma. Human biology contains complex mechanisms to protect itself from UV damage and restore cellular DNA to its original state. Due to genetic defects, XP patients have impaired DNA repair processes, leading to an extreme risk of skin cancer from an early age and a life expectancy of around 30 years. Afamelanotide, the active ingredient in SCENESSE, improves the function of skin cells which have incurred photodamage and assists these cells to repair DNA through several mechanisms, including nucleotide excision repair (NER). CLINUVEL is conducting clinical trials in XP-C and XP-V patients, as well as healthy volunteers, to evaluate the safety and efficacy of afamelanotide as a DNA regenerative therapy.